CPA is a UKAS companyIntroduction to ISO 15189Overview and mapping to current CPA StandardsCPA is a UKAS company Implementation of change Transition Steering Groups Steering Group Aims & remit Structure of CPA Standards Structure of ISO 1518 Steering Group ! Gap anal"sisIntroductionCPA is a UKAS company Aims and o#$ecti%es& To compare and identif" the differences in the follo'ing standards& CPA Standards and ISO 1518&())* CPA Standards and ISO 1518&()1( CPA POCT Standards and ISO ((8*)& ())+ Output summer ()1(& ,eport on the mapping #et'een standardsSteering Group 1CPA is a UKAS companyCurrent CPA Standard StructureCPA is a UKAS companyUnique alphanumeric and titleExplanatory textUnique alphanumeric and clauseExplanatory notesCross referenceto ISO 15189CPA is a UKAS companyCPA Standards as a process modelCPA is a UKAS companyCurrent CPA structureCPA is a UKAS companyISO 15189:!1 structure41 Or!anisation and mana!ement responsi"ility4# $uality mana!ement system 4% &ocument control44 Ser'ice a!reements 45 Examination "y referral la"oratories4( External ser'ices and supplies4) *d'isory ser'ices48 +esolution of complaints49 Identi,cation and control of nonconformities41- Correcti'e action411 .re'enti'e action41# Continual impro'ement41% Control of records414 E'aluation and audits 415 /ana!ement re'ie04 /ana!ement requirementsCPA is a UKAS companyISO 15189:!1 structure51 .ersonnel 5# *ccommodation and en'ironmental conditions 5% 1a"oratory equipment2 rea!ents and consuma"les54 .re3examination processes 55 Examination processes 5( Ensurin! quality of examination results 5) .ost3examination processes58 +eportin! of results 59 +elease of results51- 1a"oratory information mana!ement5 4echnical requirementsCPA is a UKAS company -.ample& /01/& -%aluation and audit 1uni2ue numeric clause and title3 /01/0+& Internal audit 1uni2ue numeric su#!clause and title3 ,e2uirement 4otes for guidance 5not a re2uirement6ISO 15189:!1 structureCPA is a UKAS companyCPA is a UKAS company Other %aria#les to consider 7ull gap anal"sis 8ocumentar" Practical assessment approach 9an" areas of concordance Simple gaps in the order and structure 9ore comple. gaps #et'een re2uirements some ne': some modifiedSteering Group" Gap anal#sisCPA is a UKAS company Seminars Simplified gap anal"sis presented and pro%ided 4e' and modified re2uirements descri#ed Assessments are to ISO 1518 and CPA Standards$elp wit% t%e processCPA is a UKAS companyIntroduction to ISO 15189Overview and mapping to current CPA Standards